Type 2 Diabetes
Conditions
Brief summary
The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.
Interventions
OTHERherbal extract; root of woody shrub grown in India/Sri-Lanka
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * Between 18 and 75 years of age * Male or non-pregnant, non-lactating female, at least 6 weeks postpartum * If of childbearing potential, is practicing birth control * BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2 * If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
Exclusion criteria
* Uses insulin for glucose control or has type 1 diabetes * History of diabetic ketoacidosis. * Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks. * Active malignancy * Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure * End state organ failure or status post organ transplant * History of renal disease * Current hepatic disease * History of severe gastroparesis * Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV * Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose * Clotting or bleeding disorders * Allergic or intolerant to any ingredient found in the study products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| positive AUC for plasma glucose | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points. | 4 hours |
Countries
United States
Outcome results
None listed